This program funds investigator-initiated small-molecule drug discovery and development projects, providing access to NIH experts and contract research organizations for medicinal chemistry, pharmacokinetics, toxicology, formulation, GMP synthesis, and Phase I clinical testing. It uses a phased cooperative agreement mechanism with milestone-based continued support, focusing on reducing development risk to enable late-stage therapy advancement.
Eligible applicants include a wide range of government entities, educational institutions, nonprofits, for-profit organizations including small businesses, tribal governments, and foreign institutions. Collaborative, cross-disciplinary teams are encouraged to develop competitive projects.